The present invention relates to a transfer adaptor for effecting fluid communication between a vial and another container. The invention is especially, but not exclusively, suited to use in the reconstitution of injectable preparations.
It is common practice in hospitals to reconstitute injectable preparations provided in septum-sealed vials by piercing the septum with a wide bore needle and introducing sterile water or other appropriate liquid from a syringe attached to the latter. The sterile water is first drawn into the syringe from a sterile-sealed ampoule. The wide bore needles and ampoules are disposed of after use, which is wasteful.
Next, at least some of the reconstituted preparation is taken back up into the same syringe via the needle. The wide bore needle is then removed from the syringe and disposed of. It is replaced by a narrow bore needle for injection into the patient (intramuscularly, subcutaneously etc as appropriate).
Subsequent doses, if any, are taken up in the same way, using a new wide bore needle for uptake at each occurrence, followed by disposal of same and substitution by another narrow bore needle. It is apparent that this procedure in general is very wasteful of needles. Moreover, it tends to cause degradation of the septum, especially with multiple use, resulting in a loss of sterility.
The primary mechanism of this degradation is known as "coring" whereby the opening at the needle tip removes a section of the septum. The resulting fragment may fall into and contaminate the contents of the vial or else block the needle. The wide bore needles are used for uptake, inter alia to minimize coring, but cannot completely overcome the problem.
FIG. 1 shows a known device 1 for multiple extraction from a vial after reconstitution by the conventional method. This device provides a hollow steel needle 3 terminating in a female luer 5 at the end 7 opposite to the open needle point 9. The needle is used to pierce the septum 11 of a vial.
Syringes without needles attached are then successively attached to the luer to draw-up individual doses. The flange 13 limits the extent of insertion and the cap 15 is used to close the device between uses. However, this known system does not solve the problem of coring and septum degradation, if a wide bore needle is first employed to reconstitute the preparation in the vial.
It is also known to provide a transfer adaptor comprising a steel needle having a point at each end, thereby to transfer contents between two septum-sealed bottles, an integral collar or shroud surrounding each point.
All such transfer systems described above employ steel needles of one kind or another. However, recently there has been a growing demand to minimize use of such needles. The intention is to avoid accidental pricks or scratches from needles which may be contaminated with virally infected blood. There have been several reported incidents of hospital staff becoming infected with AIDS or hepatitis B in this way.